Breast CancerNCT06635239
Massive Open Online Course (MOOC) for Women With Breast Cancer
A study testing Co-creation and assessment in people with Breast Cancer, run by Yolanda Alvarez-Perez at 1 site in Spain.
Trial summary
The goal of this clinical trial is to promote Person-Centered Care and improve Health Literacy and Digital Health Literacy in women with breast cancer through the development of a Massive Open Online Course (MOOC) co-created with women with breast cancer. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Co-creation and assessment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteSpain
- Study dates
- 17 Jan 2020to 31 Jan 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Adult women ( ≥18 years old)
- Speak Spanish
- With internet at home or smartphone
- Currently have or have had breast cancer (currently disease-free)
- Families/caregivers of women with breast cancer and healthcare professionals involved in breast cancer management (oncologists, gynaecologists, nurses, psycho-oncologists, etc.)
Who cannot join
- No exclusion criteria were applied based on diagnosis date, current or past treatment, nationality, Health Literacy and Digital Health Literacy level and knowledge about Person-Centred Care or breast cancer.
- In the assessment of the MOOC's acceptability and effectiveness, participants involved in co-creating the MOOC will be excluded.
Trial locations and contacts
1 site in 1 country.
Spain1 site
Servicio de Evaluación del Servicio Canario de la Salud
Santa Cruz de Tenerife, Santa Cruz de Tenerife, 38109
About this study
Official title: Massive Open Online Course for Women With Breast Cancer: Development and Evaluation of an Intervention on Person-Centered Care and Digital Health Literacy in Breast Cancer
The goal of this clinical trial is to promote Person-Centered Care and improve Health Literacy and Digital Health Literacy in women with breast cancer through the development of a Massive Open Online Course (MOOC) co-created with women with breast cancer.
- Conditions
- Breast Cancer
- Being tested
- Co-creation and assessment
- Keywords
- Massive Open Online Course, Digital Health Literacy, Health Literacy, Person-Centered Care
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Co-creation and assessmentOther
- MOOC co-creation: development of a MOOC initially structured into modules consisting of a variety of downloadable educational resources such as videos, audios, infographics, texts, etc., covering several units related to Person-Centered Care (Shared Decision-Making, strategies for managing the clinical encounter, Patient Decision Aids, etc.) and Digital Health Literacy (skills, tools, etc.). These resources will serve as the central focus of the educational intervention, and may undergo appropriate adjustments established during the co-creation sessions.
- MOOC acceptability and effectiveness: evaluation of the MOOC in terms of effectiveness (level of Health Literacy, Digital Health Literacy, and knowledge acquired) and acceptability (usability, areas for improvement, etc.)
| Study group | Role | What they receive |
|---|---|---|
| Single-arm intervention | Experimental | Co-creation with women with breast cancer, their families, and healthcare professionals of a MOOC aimed at women with breast cancer; and evaluation of the MOOC's effectiveness and acceptability. Receives: Other: Co-creation and assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Digital Health Literacy
Digital Health Literacy through the eHealth Literacy Scale (eHEALS). It is an 8-item scale that uses a 5-point Likert scale to answer each question with response options ranging from "strongly agree" to "strongly disagree", resulting in a total score ranging from 8 to 40.
Measured: Immediately after the intervention
Health Literacy
Health Literacy through the Health Literacy Survey European Questionnaire-16 items (HLS-EU-Q16). It is an abbreviated version of the Health Literacy Survey European Questionnaire (HLS-EU-Q) and consists of 16 items, with each question answered by choosing one response from the options: 'very difficult', 'fairly difficult', 'fairly easy', and 'very easy' giving a total score from 16 to 64.
Measured: Immediately after the intervention
Knowledge acquired
Knowledge acquired before study each unit of the MOOC using a scale designed specifically for the study and in accordance with the content of each unit
Measured: Immediately after the intervention
Acceptability of MOOC
Acceptability (usability, areas for improvement, etc.) of the MOOC using a scale designed specifically for the study, adhering to the methodology of the technology acceptance model (TAM)
Measured: Immediately after the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2024
- Study start17 Jan 2020
- Primary completion31 Jan 2023
- Study completion31 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yolanda Alvarez-Perez
- Sponsor type
- University, hospital or other
- Collaborators
- Servicio Canario de Salud, Fundación Canaria Instituto de Investigación Sanitaria de Canarias, University of La Laguna, University of Barcelona, FEFOC fundation, Parc Taulí Hospital Universitari, Hospital Clinic of Barcelona, Universitat Autonoma de Barcelona
- Responsible party
- Sponsor-investigator, Yolanda Alvarez-Perez, Servicio Canario de Salud
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06635239
- Sponsor's protocol ID
- PIFIISC 19/24
- Other IDs
- CHUNSC_2019_61
- Status last verified
- Oct 2024
- First submitted
- 4 Oct 2024
- Last updated
- 10 Oct 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Alvarez-Perez Y, Duarte-Diaz A, Toledo-Chavarri A, Abt-Sacks A, Ramos-Garcia V, Torres-Castano A, Rivero-Santana A, Perestelo-Perez L. Digital Health Literacy and Person-Centred Care: Co-Creation of a Massive Open Online Course for Women with Breast Cancer. Int J Environ Res Public Health. 2023 Feb 22;20(5):3922. doi: 10.3390/ijerph20053922.
PubMed 36900935
Study at a glance
From the registry record, last updated by the sponsor on 10 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Massive Open Online Course for Women With Breast Cancer: Development and Evaluation of an Intervention on Person-Centered Care and Digital Health Literacy in Breast Cancer
- ClinicalTrials.gov ID
- NCT06635239
- Acronym / sponsor ID
- PIFIISC 19/24
- Conditions
- Breast Cancer
- Keywords
- Massive Open Online Course, Digital Health Literacy, Health Literacy, Person-Centered Care
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Yolanda Alvarez-PerezUniversity, hospital or other
- Collaborators
- Servicio Canario de Salud, Fundación Canaria Instituto de Investigación Sanitaria de Canarias, University of La Laguna, University of Barcelona, FEFOC fundation, Parc Taulí Hospital Universitari, Hospital Clinic of Barcelona, Universitat Autonoma de Barcelona
- Study start
- 17 Jan 2020 (actual)
- Primary completion
- 31 Jan 2023 (actual)
- Study completion
- 31 Jan 2023 (actual)
- First posted
- 10 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this clinical trial is to promote Person-Centered Care and improve Health Literacy and Digital Health Literacy in women with breast cancer through the development of a Massive Open Online Course (MOOC) co-created with women with breast cancer.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single-arm intervention | Experimental | Other: Co-creation and assessmentCo-creation with women with breast cancer, their families, and healthcare professionals of a MOOC aimed at women with breast cancer; and evaluation of the MOOC's effectiveness and acceptability. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- Adult women ( ≥18 years old)
- Speak Spanish
- With internet at home or smartphone
- Currently have or have had breast cancer (currently disease-free)
- Families/caregivers of women with breast cancer and healthcare professionals involved in breast cancer management (oncologists, gynaecologists, nurses, psycho-oncologists, etc.)
Key exclusion criteria (2 listed)
- No exclusion criteria were applied based on diagnosis date, current or past treatment, nationality, Health Literacy and Digital Health Literacy level and knowledge about Person-Centred Care or breast cancer.
- In the assessment of the MOOC's acceptability and effectiveness, participants involved in co-creating the MOOC will be excluded.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Co-creation and assessment1. MOOC co-creation: development of a MOOC initially structured into modules consisting of a variety of downloadable educational resources such as videos, audios, infographics, texts, etc., covering several units related to Person-Centered Care (Shared Decision-Making, strategies for managing the clinical encounter, Patient Decision Aids, etc.) and Digital Health Literacy (skills, tools, etc.). These resources will serve as the central focus of the educational intervention, and may undergo appropriate adjustments established during the co-creation sessions. 2. MOOC acceptability and effectiveness: evaluation of the MOOC in terms of effectiveness (level of Health Literacy, Digital Health Literacy, and knowledge acquired) and acceptability (usability, areas for improvement, etc.) | Other | Single-arm intervention |
Primary outcome
Digital Health Literacy
Time frame: Immediately after the intervention
Digital Health Literacy through the eHealth Literacy Scale (eHEALS). It is an 8-item scale that uses a 5-point Likert scale to answer each question with response options ranging from "strongly agree" to "strongly disagree", resulting in a total score ranging from 8 to 40.
Health Literacy
Time frame: Immediately after the intervention
Health Literacy through the Health Literacy Survey European Questionnaire-16 items (HLS-EU-Q16). It is an abbreviated version of the Health Literacy Survey European Questionnaire (HLS-EU-Q) and consists of 16 items, with each question answered by choosing one response from the options: 'very difficult', 'fairly difficult', 'fairly easy', and 'very easy' giving a total score from 16 to 64.
Knowledge acquired
Time frame: Immediately after the intervention
Knowledge acquired before study each unit of the MOOC using a scale designed specifically for the study and in accordance with the content of each unit
Acceptability of MOOC
Time frame: Immediately after the intervention
Acceptability (usability, areas for improvement, etc.) of the MOOC using a scale designed specifically for the study, adhering to the methodology of the technology acceptance model (TAM)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Oct 2024.
- Results publication: PubMed 36900935Alvarez-Perez Y, Duarte-Diaz A, Toledo-Chavarri A, Abt-Sacks A, Ramos-Garcia V, Torres-Castano A, Rivero-Santana A, Perestelo-Perez L. Digital Health Literacy and Person-Centred Care: Co-Creation of a Massive Open Online Course for Women with Breast Cancer. Int J Environ Res Public Health. 2023 Feb 22;20(5):3922. doi: 10.3390/ijerph20053922.
- Individual participant dataSharing planned: No
Related trials for Breast Cancer
Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
RecruitingPhase 2
Gene Signatures to Guide HR+MBC Therapy in a Diverse Cohort
Invasive Mammary Carcinoma, Metastatic Breast Cancer
Not yet recruitingObservational study
Comparison of Reliability, Time Cost, and Participant Comfort of Lymphedema Assessments in Upper Extremity
Lymphedema, Upper Extremity Lymphedema
RecruitingPhase 3
A Study of Camrelizumab Plus Chemotherapy in Combination With or Without Famitinib as Neoadjuvant Therapy in Participants With Triple Negative Breast Cancer (BCTOP-T-N01)
TNBC - Triple-Negative Breast Cancer
RecruitingPhase 3
Testing Whether Hormone Therapy With Ribociclib is as Effective as Chemotherapy Followed by Hormone Therapy With Ribociclib for the Treatment of High Anatomic Stage Breast Cancer With Low Recurrence Risk, The RxFINE-Low Trial
Anatomic Stage II Breast Cancer AJCC v8, Anatomic Stage IIIA Breast Cancer AJCC v8
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Co-creation and assessment in people with Breast Cancer, run by Yolanda Alvarez-Perez at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Digital Health Literacy (time frame: Immediately after the intervention). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06635239, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Oct 2024.